Autopsy report · NCT01387932

HepaSphere/Quadrasphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Cancer

“The clinical study was terminated due to the inability to meet target enrollment.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 2 months before it started.
• Ran for about 9 years 8 months before it stopped.
• 235 participants enrolled.
• Results were posted on the registry 9 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Merit Medical Systems, Inc.

Sponsor type

Industry

Conditions

Hepatocellular Carcinoma

Interventions

HepaSphere/QuadraSphere Microspheres; PVA, lipiodol, doxorubicin

Participants

235

Sites

23

Countries

Belgium, France, Greece, Italy, United States

Trials that died the same way

• An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis
  “Study terminated due to lack of enrollment of the target population. There were no safety, efficacy, or regulatory interaction involved in the decision to stop enrollment.” (86% match in meaning)
• Comparison of the Live Birth Rate Between the PPOS and the GnRH Antagonist Protocol in Patients Undergoing IVF
  “The study was terminated due to difficulty in recruiting patients.” (85% match in meaning)
• Alvimopan Use in Polytraumatized Patients
  “This study was terminated due to failure to enroll, a low volume of patients met criteria.” (84% match in meaning)
• Study of the Efficacy and Safety of Ferrlecit in the Maintenance Dosing in Hemodialysis Patients.
  “The study was terminated because of significant enrollment challenges” (84% match in meaning)
• Aspirin as a Novel Anti-Inflammatory Modality in the Fontan Patients
  “This study was terminated due to inability to recruit sufficient patients.” (84% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.